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OpenTrials
Completed

NCT Number: NCT02448303

Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer

Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small cell lung cancer.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Western Regional Medical Center/Cancer Treatment Center of America

Goodyear, Arizona, 85338, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women ≥ 18 years of age
  • ECOG performance status of 0 or 1
  • Histologically confirmed recurrent or metastatic NSCLC (adenocarcinoma, large cell, squamous cell, or not otherwise specified) that has either progressed during or after platinum-based chemotherapy
  • Received at least 1 platinum-based chemotherapy regimen. Note: Subjects with EGFR mutations or ALK translocations are required to have received prior therapy with appropriate TKI; prior platinum-based chemotherapy is not required for this specific patient population

Exclusion criteria

  • Prior malignancy (other than lung cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years
  • Known central nervous system metastases and/or carcinomatous meningitis
  • Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass
  • Breastfeeding or pregnant

Treatment and study plan

Pembrolizumab

Drug

Other names: Keytruda

Acalabrutinib

Drug

Other names: ACP-196

Primary outcomes

  1. Number of Participants With Overall Response

    Time frame: Every 12 weeks for up to 2 years

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Sponsors and collaborators

Lead sponsor

Acerta Pharma BV

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

A Phase 2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Advanced Non-small Cell Lung Carcinoma

Acronym: KEYNOTE166

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 19, 2015
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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